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Purpose

This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Healthy adults, ages 18-55
  • Current non-medical use of opioids and sedatives

Exclusion Criteria

  • Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/hypnotics
  • Seeking treatment for drug use
  • Significant medical problems

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)
Masking Description
This is a randomized, double-blind, double-dummy, placebo- controlled design

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Oral opioid agonist
Participants will receive non-therapeutic experimental doses of active or placebo oral opioid agonist. Active opioid agonist/placebo will be administered once per session and will be administered orally.
  • Drug: Opioid Agonist
    Active opioid agonist or placebo, administered orally
Experimental
Oral sedative
Participants will receive non-therapeutic experimental doses of active or placebo oral sedative. Active sedative/placebo will be administered once per session and will be administered orally.
  • Drug: Sedatives
    Active sedative or placebo, administered orally
Experimental
Opioid agonist/sedative
Participants will receive non-therapeutic, experimental doses of active opioid agonist/placebo in combination with non-therapeutic, experimental doses of active sedative/placebo. Opioid/placebo and sedative/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid and sedative doses will be administered orally.
  • Drug: Opioid Agonist
    Active opioid agonist or placebo, administered orally
  • Drug: Sedatives
    Active sedative or placebo, administered orally

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Center on Drug and Alcohol Research
Lexington, Kentucky 40208
Contact:
Paul A Nuzzo, M.A.
859-323-0002
pnuzz2@email.uky.edu

More Details

NCT ID
NCT04315181
Status
Recruiting
Sponsor
Sharon Walsh

Study Contact

Konnor QX Long, B.S.
859-257-4581
konnor@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.